Kornimate/medical-research-clean huggingface dataset:
cardiac rhythm monitoring after acute decompensation for heart failure

Conditions: Heart Failure

Summary: the carrying on for heart failure (hf) study is a national, prospective, post market interventional, multi-center, open-label, pilot trial.the purpose of the study is to assess a short term and a long term period, incidence of pre-specified clinical and arrhythmic events in patients with a low ejection fraction (ef) that are hospitalized for acute cardiac decompensation.

the carrying on for heart failure (hf) study is a national, prospective, post market interventional, multi-center, open-label, pilot trial designed in two phases. the purpose of the study is to assess a short term (6 months follow-up - phase 1) and a long term period (24 months follow-up - phase 2), incidence of pre-specified clinical and arrhythmic events in patients with a low ejection fraction (ef) that are hospitalized for acute cardiac decompensation. a previously implanted reveal® xt device will be used to collect heart rhythm information.

Eligibility criteria:
inclusion criteria: * subject with a history of at least one heart failure (hf) hospitalization (as defined in the european society of cardiology or american college of cardiology/american heart association guidelines), emergency department (ed) visit, or urgent office visit necessitating intravenous (iv) diuretic or augmentation of oral diuretic, iv inotropic, or iv vasodilator or other hf parenteral therapy within 15 days prior to device implant * subject has an implanted reveal® xt device (less than 15 days post implant); * ejection fraction (ef) less than 40 percent * patient with access to a telephone line * patient or the patient's caregiver is willing and able to use the medtronic carelink® network monitor and to perform the required duties at home or has a family member or assistant perform those duties * age greater than 18 years old * patient is willing and able to comply with the clinical investigation plan and willing to remain available for follow-up visit, through study closure * patient (or patient's legally authorized representative) is willing and able to sign and date the study informed consent exclusion criteria: * new york heart association (nyha) class iv (chronic or ambulatory) * planned or previous implant of implantable cardioverter-defibrillator or pacemaker device * patient's life expectancy is less than one year due to non cardiovascular disorders, in the opinion of the physician * severe chronic obstructive pulmonary disorder (copd) * chronic atrial fibrillation at time of enrollment * st segment elevation at time of electrocardiogram * cognitive disease * pregnancy or childbearing potential and not on reliable contraceptive * anticipated compliance problem or participation in another competitive trial

Keywords: reveal® xt acute heart failure low ejection fraction reveal® xt implanted
percutaneous transluminal forceps biopsy

Conditions: Biliary Stricture; Biopsy Wound; Oncology

Summary: to evaluate during a 7 months period the efficacy, safety and accuracy of percutaneous transluminal forceps biopsy combined with transhepatic biliary drainage in patients with biliary stricture

biological parameters of liver function, histopathology of specimens, comparison with others clinical and pathological data (imaging follow up, percutaneous biopsy, surgical biopsy, endoscopic biopsy) were recorded comparison between pathological findings of surgery or endoscopy or percutaneous biopsy and specimens coming from biliary forceps biopsy follow up of the patient 12 months after biopsy evaluation of complications, accuracy

Eligibility criteria:
inclusion criteria: * patients with biliary strictures without histology available exclusion criteria: * pregnant patients * children
hs students mandatory universal student instruction in cpr appraised learning- is the mandate working?

Conditions: Sudden Cardiac Arrest

Summary: this study will help to provide better input to state health and education departments to improve the processes for cpr education. this will also help the ep council explore the opportunities to partner with other professional societies and other stake holders that have interest in this topic. engagement of private-public partnerships for improving overall cpr education.

schools should incorporate cpr education programs in the schools that will increase the knowledge, skills and awareness among high school children. it is important to note that, cpr training of young children, increases the self confidence, esteem, responsibility and contribution to their community.moreover, it is clearly shown that, high school children has the required physical strength, maturity and positive attitude towards performing cpr in family members, friends and strangers in the community. although some studies suggest benefit of periodic retraining, few studies have attempted to collectively identify contributing factors to comprehension.it is an attempt to identify national distribution of training efforts and factors implicated in comprehension among high school students.

Eligibility criteria:
inclusion criteria: * high school students completing voluntary survey exclusion criteria: * inability to give consent * inability to complete survey

Keywords: cpr education high school students
exploring new approaches in reaching behavior post stroke

Conditions: Stroke

Summary: after 4 weeks of training the hypothesis that the more natural training program would yield greater functional changes was proven correct.

analysis indicated that both methods improved reaching without trunk use reaching performance scale (rps), but the trunk -stabilized group led to more significant changes. training under less restrictive conditions associated with task-related training (trt) (auditory feedback from trunk sensor) as compared to stabilized trt, led to improved functional and impairment measure scores (wmft, fm and shoulder flexion). conclusion: fading feedback with both training methods, during extended trt reaching/grasping practice generally led to some improvements. however, as demonstrated by impairment and functional outcome measures, using trt with an auditory feedback signals is a more effective approach than forcing the stabilization of the trunk during rehabilitation of the upper-limb.

Eligibility criteria:
inclusion criteria: * individuals all scored between 20 and 44 on the upper-arm subsection of the fugl-meyer scale (fm- poole \& whitney, 1988) and demonstrated some trunk movement during the pretest reaching performance scale measures (rps, levin 2006) exclusion criteria: * individuals were referred if they had no receptive aphasia, apraxia or other cognitive deficits.

Keywords: rehabilitation, reaching, stroke
prospective, multi-center, observational, whole blood specimen collection study in participants with rheumatoid arthritis with inadequate response or intolerance to a dmard starting a new bdmard or tsdmard treatment +/- csdmard

Conditions: Rheumatoid Arthritis

Summary: the primary goal of this study is to assess a cfdna-based blood test using genetic, transcriptomic and/or epigenetic information to help doctors predict the best treatment options for rheumatoid arthritis (ra) patients with inadequate response or intolerance to previous therapies.

prima - 102 aims to predict response to bdmard or tsdmard therapy through analysis of cfdna in blood. prima - 102 will enroll participants with inadequate response or intolerance to previous therapies. participants will undergo screening and baseline visits, followed by the initiation of new bdmard or tsdmard therapy per standard of care. the study will evaluate treatment response and disease activity at a 12-week follow-up visit. blood will be drawn and clinical outcome assessments performed at baseline and at the 12-week follow-up visit.

Eligibility criteria:
inclusion criteria: * ability to understand and provide written informed consent. * male or female ≥18 years of age at enrollment. * diagnosis of rheumatoid arthritis at the time of enrollment. * prior treatment with at least 1 csdmard, bdmard, or tsdmard * planning to initiate a new bdmard (+/- csdmard) or tsdmard (+/- csdmard), within 1 month after enrollment. * moderate to high clinical disease activity index (cdai) of (\>10) with a minimum 4 tender joints and 4 swollen joints at the time of screening. exclusion criteria: * unsuitable for participation in the opinion of the principal investigator.
the effect of eszopiclone on the arousal threshold in sleep apnea syndrome

Conditions: Obstructive Sleep Apnea

Summary: the purpose of this study is to find out whether taking eszopiclone (lunesta) changes the breathing effort required to briefly wake people with obstructive sleep apnea from sleep (respiratory arousal threshold). we would like to see if taking eszopiclone can reduce the severity of obstructive sleep apnea in some people (those that have a low respiratory arousal threshold; i.e. wake up easily to respiratory stimuli).

obstructive sleep apnea is an exceedingly common disease with major neurocognitive and cardiovascular consequences. the current primary treatment e.g. continuous positive airway pressure (cpap) is effective but poorly tolerated by many patients particularly those with mild-moderate disease. secondary treatments such as oral appliances to advance the mandible or surgical procedures to enlarge the airway are commonly appealing to the patient. however, these approaches have only modest success in reducing apnea frequency to an acceptable level. thus, finding tolerable and effective therapy for sleep apnea remains an important objective. the causes of sleep apnea vary between patients. targeted therapy according to the underlying causes of sleep apnea in individual patients is likely to be most effective. however, current therapeutic options for sleep apnea are quite limited. the purpose of this physiological research study is to determine if taking eszopiclone (lunesta)changes the breathing effort required to briefly wake people with obstructive sleep apnea from sleep (the arousal threshold) and if administration of the sedative medication eszopiclone (lunesta) to certain sleep apnea patients (those with a low arousal threshold ie wake up easily) would be beneficial.

Eligibility criteria:
inclusion criteria: * 18-64 years old * untreated obstructive sleep apnea exclusion criteria: * nadir sao2 \<70% on a baseline psg * medications known to affect either sleep, breathing or muscle activity * major co-morbidities apart from sleep apnea * allergy to lidocaine, oxymetazoline hcl, or eszopiclone * women who are pregnant

Keywords: obstructive sleep apnea arousal threshold sedative medication upper airway
improving search strategy for identifying urgent conditions on the chest x-ray

Conditions: Using Expert Visual Search Strategy to Train Students to Read the Chest X-ray

Summary: currently, teaching x-ray interpretation to medical students is not standardized, and is generally not very effective. objective: the goal of our study is to evaluate whether directly teaching an expert search strategy for x-ray interpretation to 3d year medical students is effective. methods: * an expert's visual search strategy was recorded using a gaze-tracking device. the search strategy was then reproduced using a dynamic cursor moving across the corresponding chest x-ray, and incorporated into a teaching program accessible via the internet. * participants are 3rd year medical students who will be randomized into two groups. the experimental group will have access to the teaching program as described. the control group will have access to the same x-rays but not the expert's search strategy. * at the end of the study period the investigators will collect performance data (the participants' accuracy at reading a series of chest x-rays) and process data (using gaze-tracking to evaluate the participants' search strategies); the experimental and control groups will be compared. expected results: the investigators expect the group trained in expert search strategy to show improved accuracy at reading chest x-rays, and an improvement in their visual search strategy


Eligibility criteria:
inclusion criteria: * 3rd year medical students enrolled in medicine or surgery rotations during the planned study period

Keywords: visual search strategy, training, chest x-ray
cryoablation system fim/ce mark study

Conditions: Atrial Fibrillation

Summary: multi-center, open label, prospective clinical study to establish the acute safety and performance of the cryterion cardiac cryoablation system

this is a single-arm, open-label clinical study using a cryoablation balloon device to isolate pulmonary veins during an atrial fibrillation ablation procedure. cryo is a scientifically proven energy source used to create a thermal injury during endocardial ablation. the investigational device uses current technology with minor design modifications and will be studied to validate similarities in the safety and performance parameters compared to literature.

Eligibility criteria:
main inclusion criteria: * currently scheduled for a de novo ablation of atrial fibrillation (af) defined as af with self-terminating episodes lasting no longer than 7 continuous days (paf) main exclusion criteria: * in the opinion of the investigator, any known contraindication to an af ablation, transesophageal echocardiogram (tee). or anticoagulation * any duration of continuous af lasting longer than 7 days * history of previous left atrial ablation or surgical treatment for atrial fibrillation/atrial flutter/atrial tachycardia (af/afl/at) * more than four (4) electrical cardioversions in the year prior to enrollment excluding cardioversions performed within 24 hours of arrhythmia onset. * significant structural heart disease or implanted cardiac devices
study to evaluate the safety, tolerability, and efficacy of otx-csi in subjects with dry eye disease.

Conditions: Dry Eye Disease

Summary: to assess the safety, tolerability and efficacy of a single dose of otx-csi, a sustained release cyclosporine drug product, in subjects with dry eye disease.

randomized, multi-center, double-masked, vehicle-controlled, phase 1/2 study to evaluate the safety, tolerability, and efficacy of otx-csi in subjects with dry eye disease. the subjects will be followed for approximately 16 weeks after product insertion

Eligibility criteria:
inclusion criteria: * dry eye disease diagnosis * vas eye dryness severity score ≥ 30. exclusion criteria: * are unwilling to discontinue use of contact lenses * are unwilling to withhold use of artificial tears.

Keywords: cyclosporine intracanalicular insert
glycemic optimization treatment study

Conditions: Diabetes Mellitus, Type 2

Summary: to compare the frequency of severe hypoglycemia events for 5 dosing algorithms of lantus®, each of varying intensity and defined by their end-of -study target for self monitored plasma glucose(smpg), in patients with type 2 diabetes mellitus, with inadequate glycemic control (a1c greater than or equal to 7.0%) on oral antidiabetic drug therapy(oad).


Eligibility criteria:
inclusion criteria: 1. subjects must give their signed informed consent. 2. diagnosis of type 2 dm for at least 6 months. 3. males and females greater than or equal to 18 years of age. 4. a1c greater than or equal to 7.0%. 5. current (last 2 months) diabetes therapy with oral anti-hyperglycemia agents only. 6. demonstrated willingness and ability to inject insulin glargine. 7. able to understand and willing to comply with procedures required by the protocol and have access to a phone. 8. demonstrated ability and willingness to perform self-monitoring of blood glucose (smbg) and use of the algorithm calculator (al-cal). 9. bmi greater than 25.0 kg/m2. 10. subjects who, in the opinion of the investigator, should be initiated on insulin therapy. exclusion criteria: 1. cardiac status new york heart association (nyha) iii-iv (appendix a). 2. for subjects treated with metformin (glucophager, glucophage xrr, glucovancer, metaglipr , or avandametr) plus a serum creatinine greater than 1.5 mg/dl (133 μmol/l) for males or greater than 1.4 mg/dl (124 μmol) for females, the inability or unwillingness to discontinue these medications, and to remain off them through the entire study. 3. for subjects on thiazolidinediones, the inability or unwillingness to discontinue these medications and to remain off them through the entire study. 4. planned pregnancy, pregnancy, or lactation. 5. serum creatinine greater than 3.0 mg/dl (266 μmol/l). 6. serum glutamic pyruvic transaminase (sgpt) greater than 2.5 x the upper limit of normal range. 7. any current malignancy or cancer within the past 5 years (except adequately treated basal cell carcinoma or cervical carcinoma in situ). 8. diagnosis of dementia or mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 9. hypersensitivity to lantus® insulin or any of its components. 10. any disease or condition, including the abuse of illicit drugs, prescription medicines, or alcohol that, in opinion of the sponsor/investigator, may interfere with the completion of the study. 11. current (last 2 months) insulin therapy. 12. with the exception of thiazolidinediones (for all potential subjects) and for subjects who are taking metformin and have an exclusionary creatinine level, the ability or unwillingness to continue pre-study anti-hyperglycemia agents at pre-study dosages through the entire study. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
a study protocol comparing a home rehabilitation program versus e-health program in low back pain

Conditions: Chronic Low-back Pain

Summary: the aim of this randomized controlled trial is to evaluate the feasibility and effectiveness of providing an e-health rehabilitation program through a web platform performing electroanalgesia and an exercise program following the mckenzie method for patients with chronic low back pain in primary care, compared with the same home rehabilitation program but without the support of an electronic program.

a double blind clinical trial will be developed in a sample of 80 subjects with chronic low back pain. patients will receive 3 weekly sessions of electroanalgesia and an exercise program for 8 weeks, for a total of 24 sessions. the aim is to analyze the effectiveness of a home rehabilitation program vs a web platform program on disability, pain, fear of movement, quality of life, resistance of the trunk flexors, lumbar mobility in flexion and muscular electrical activity.

Eligibility criteria:
inclusion criteria: * low back pain ≥ 3 months. * age between 30 and 67 years old. * score ≥ 4 points on the roland morris disability questionnaire. * not being receiving physical therapy. exclusion criteria: * presence of lumbar stenosis. * diagnosis of spondylolisthesis. * diagnosis of fibromyalgia. * treatment with corticosteroids or oral medication in recent weeks. * history of spine surgery. * contraindication of analgesic electrical therapy. * have previously received a treatment of electrical analgesia or exercise. * central or peripheral nervous system disease. * agoraphobia

Keywords: low back pain electroanalgesia exercise program e-health randomized controlled trial
double gnrh antagonist daily dose in hyperresponding ivf/icsi cycles may prevent the ohss

Conditions: Ovarian Hyperstimulation Syndrome

Summary: the possibility to prevent the early ovarian hyperstimulation syndrome (ohss) by doubling the daily dose of gnrh-antagonist in women stimulated with the antagonist protocol who are at risk for ohss was evaluated. thirty-eight women of a study group who underwent ovarian stimulation using the gnrh-antagonist protocol and might have had their cycle cancelled because of ohss were compared to 76 women of a control group. all cases of the study group were ivf women presenting a rapid rise of e2 ≥ 3500 pg/ml on the 7th day of stimulation or later while the follicles (\> 12mm) were \> 15 in total and the biggest one was ≤ 16mm in diameter. by decreasing the rfsh dose to 100iu a day and adding an additional dose of gnrh-antagonist (0.25 twice a day), estradiol levels were lowered or reached a plateau before hcg was given. a marked decrease or plateau of estradiol levels was observed the day of oocyte retrieval while the pregnancy rate was not adversely affected when compared with an optimum ovarian response cycles. none of the women were cancelled or developed ohss. in overresponding ivf cycles, doubling the usual gnrh-antagonist daily-dose during the ovarian stimulation, the estradiol rise could be blocked while a minimal follicular stimulation may continue without the risk of ohss or adversely affect pregnancy rate.


Eligibility criteria:
inclusion criteria: * women stimulated with the antagonist protocol who are at risk of ovarian hyperstimulation syndrome exclusion criteria: * has chosen other preventive protocols (coasting and/or cryopreservation)were excluded

Keywords: gnrh antagonists ohss ovarian stimulation
immune monitoring on sipuleucel-t

Conditions: Prostate Cancer

Summary: the purpose of this protocol is perform comprehensive immune monitoring studies in patients with castration-resistant prostate cancer receiving sipuleucel-t in an effort to better understand the mechanism of action of this treatment.

the primary objectives of this study are to: 1. establish the phenotype and frequency of circulating immune cell compartments in patients undergoing treatment with sipuleucel-t. 2. determine the induction and the quality of prostate antigen-specific t cell immunity in patients undergoing treatment with sipuleucel-t. 3. correlate whole-blood rna transcript-based signatures with clinical outcomes in patients treated with sipuleucel-t. 4. evaluate the cytokine and chemokine milieu in the peripheral blood pre- and post-treatment with sipuleucel-t.

Eligibility criteria:
inclusion criteria: * age \> 18 years of age * written informed consent obtained * patients with castration-resistant prostate cancer who are initiating sipuleucel-t as standard therapy * no prior systemic chemotherapy for metastatic prostate cancer * hemoglobin \> 9 mg/dl exclusion criteria: * patients unable to understand the research protocol and/or provide informed consent

Keywords: sipuleucel-t castration resistant prostate cancer provenge